MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE Fixed Wire; dilator, esophageal

Model Number	M00558380
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the pyloric channel during an esophagogastroduodenoscopy (egd) dilation procedure to treat stenosis performed on (b)(6) 2026.During the procedure, the balloon burst when inflated.It was reported that no piece of the balloon detaches inside the patient.Additionally, the balloon was overinflated by the user.The procedure was completed with the original device.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the balloon was overinflated.Per the instruction for use (ifu), it was indicated not to exceed the inflation pressure corresponding to the maximum balloon diameter indicated on the catheter hub and package label.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Imdrf device code a1406 captures the reportable event of balloon overinflation.Block h11: investigation results the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of balloon burst could not be confirmed.The device was not returned because it was disposed.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: CRE Fixed Wire
• Common Device Name: dilator, esophageal
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Cork Limited; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50754604
• Report Number: 3005099803-2026-03744
• Device Sequence Number: 9631516
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558380
• Device Catalogue Number: M00558380
• Device Lot Number: 0040490196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown